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Taking people in AustraliaNo phase

Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea

Key facts

Who runs it
Restera, Inc.
Where
Perth, AustraliaSee the site
Trial code
Status
Recruiting
People taking part
20 people, planned
Started
Dec 2025
Expected to end
May 2029
Type of study
Interventional, 2 groups
Treatments tested
  • Neurostimulation
Record updated
24 December 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Body Mass Index (BMI) ≤ 32 kg/m2
  • AHI between 15-65 events/hour
  • Participants who have either not tolerated, have failed or refused positive airway pressure (PAP)

Who cannot take part

  • Participants taking medications that may alter body weight
  • Pregnancy or breast-feeding
  • Significant upper airway anatomic abnormalities
  • Significant positionally-dependent OSA

Where in Australia

  • University of Western AustraliaPerth, AustraliaContact: Tim FayramTaking people

About the trial

What the trial wants to find out

The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in adults with obstructive sleep apnea.

The 2 groups in the trial

  • Single TargetTreatment being tested

    Treatment: Neurostimulation

  • Dual TargetTreatment being tested

    Treatment: Neurostimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multi-center Proof-of-concept Study to Assess the Safety and Effectiveness of the Restera™ Serene™ System When Stimulating the Hypoglossal Nerve Alone or the Hypoglossal Nerve Plus the Ansa Cervicalis Nerve for the Treatment of Obstructive Sleep Apnoea in Adult Participants.
Record updated
24 December 2025